The demand for new medical devices and wearables is causing a rapid shift in the medical devices industry. The manufacturers, however, are facing significant obstacles during this transformation process due to the presence of outdated infrastructure and processes, stricter regulations, and increased competition. To overcome these issues, they are looking into digital solutions like PLM to redefine their operational strategies and speed up their go-to-market plan.
A multinational medical device manufacturer approached LTTS seeking assistance in adapting to the ever-changing market dynamics and regulatory requirements. They wanted us to redefine their business strategies by integrating various tools and systems like Adlib and Prisym 360 to avoid any unexpected delays during production deployment. Additionally, they insisted on implementing Unique Device Identifier (UDI) in compliance with the FDA's 21CFR803.20 standards.
LTTS provided assistance by offering solutions that allowed for the automation of booklet design, ensuring compliance of labels and booklets with regulations, and simplifying GxP compliance and validation, thereby reducing label design and production time and effort.